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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
November 19, 2024

How much clinical data do you actually need: Have we overestimated the EU requirements?

In the complex landscape of EU regulatory compliance, one question keeps emerging: Do you actually need clinical data for your medical device? For MedTech professionals, understanding what’s required versus what’s commonly assumed can mean the difference between streamlined compliance and unnecessary effort. In this webinar, we’ll take a close look at EU regulations to clarify when clinical data is truly necessary, and when it may not be required at all.

Join us to uncover the real standards behind EU compliance, helping you make informed decisions about your clinical data strategy.

Specifically, this webinar will help you with:
  • What’s Required and What’s Not: Get a clear understanding of when clinical data is truly necessary for compliance.
  • Navigating Requirements for Different Device Types: Learn about specific requirements for software as a medical device (SaMD), low-risk devices, and orphan devices.
  • Avoiding Unnecessary PMCF: Discover when post-market clinical follow-up (PMCF) is essential, and when it can be scaled back or avoided.
  • Right-Sizing Your Clinical Strategy: Understand the regulatory standards that let you streamline your approach, saving time and resources.

Watch the webinar
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Who should attend?
  • Clinical Affairs Professionals and Management
  • Clinical Operations Professionals and Management
  • Regulatory Professionals and Management
  • Medical Device Executives
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Hosted by

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SPEAKER:
DR. BASSIL AKRA

CEO and President
AKRA TEAM
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MODERATOR:
CHRIS RUSH

Solutions Engineer,
Greenlight Guru
Dr. Bassil Akra

Dr. Bassil Akra is CEO and President of AKRA TEAM in Germany (GmbH) and the USA (Inc), a globally acting consultancy company. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations. Dr. Akra is also member of the Board of the EU Association TEAM PRRC. He is also member of the MDR EY Survey Advisory Group.

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About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

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